Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.

In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.

These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.

This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Read More

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Patients shouldn’t be penalized by their biology if they need a drug that isn’t on formulary. Patients shouldn’t face exorbitant out of pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else. After all, what’s the point of a big co-pay on a costly cancer drug? Is a patient really in a position to make an economically-based decision? Is the co-pay going to discourage overutilization? Is someone in this situation voluntary seeking chemo? Of course not. Yet the big co-pay or rebate on the costly drug can help offset insurers’ payments to the pharmacy, and reduce average insurance premiums. But sick people aren’t supposed to be subsidizing the healthy.

Wow. This may seem like common sense to some readers, but it is revolutionary to hear from a senior American government official, and indeed a Republican one no less.

In a new paper, Victor Laurion and I have chronicled the ways in which American politicians at the highest levels have blindly embraced the opposite point of view for half-a-century. This sort of ideological adherence to simplistic economic reasoning (which James Kwak calls ‘economism‘) is why U.S. health insurance exposes patients to all sorts of deductibles, copays, and coinsurance. As a result, even insured Americans find themselves “underinsured” — denied access to care or falling into bankruptcy if they stretch to pay nonetheless. Read More

A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000 stated:

“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identiﬁed but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).

In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.

This week features a first time visit from Carl Ameringer, professor of health policy and politics at Virginia Commonwealth University in Richmond, Virginia. A lawyer with a PhD in political science, he is an expert on issues surrounding our national debate on health care reform. We discuss his latest book “US Health Policy and Health Care Delivery: Doctors, Reformers, and Entrepreneurs,” published by Cambridge University Press. Our conversation connects the past and future of American health care, from 19th century development to the ACOs of the ACA. We close with some reflections on path-dependence: is American exceptionalism a permanent impediment to health sector rationalization, or does it provide some models for improvement? Muddling through history, policy, and law has rarely been more edifying, and we hope you enjoy the conversation as much as we did.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher RadioTunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.

The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:

Arguably the most popular provision of the Affordable Care Act (ACA), section 2714 (42 U.S.C. § 300gg-14) provides that individuals may stay on their parent’s insurance plan until they are twenty-six years of age. A 2013 Commonwealth Fund survey found 7.8 young adults gained new or better insurance through this ACA provision, and a repeat survey in 2016 found the uninsured rate for young adults, ages 19-34, dropped from 28% to 18%. On its face, it is difficult to find any harm caused by this provision. Healthy young people have insurance, despite continuing education or lack of gainful employment, and are presumably lowering costs by being in the risk pool. However, this provision can lead to unforeseen pitfalls, including medical debt, because of the way it interacts with the growing trend of increased cost sharing and narrow networks. These trends acutely impact students in higher education, because students who study even a modest distance from their parents’ home are unlikely to have access to nearby “in-network” providers, and because students’ medical needs more often tend to come in the form of unexpected emergencies. In this post, I will highlight my personal experience with Section 2714, as a graduate student, and explore policy and possibilities for reform.

An Emergency and a Choice: Applying Section 2714

Like many young adults, I remained on my parents’ insurance when I went to college. Specifically, I remained on my mom’s insurance because I was in law school and continue to be an advocate for the ACA program. But when my mom began a new job at a different hospital her insurance changed and so did the medical network. The only “in network” coverage was through the hospital that employed her, and that was hour and forty-five minutes away. I didn’t view this as an issue until the unexpected happened. Read More

It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:

Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.